An investigation of aspects of radiochemical purity of <sup>99m</sup>Tc-labelled human serum albumin nanocolloid.

Details

Serval ID
serval:BIB_55DDE848CEBB
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
An investigation of aspects of radiochemical purity of <sup>99m</sup>Tc-labelled human serum albumin nanocolloid.
Journal
EJNMMI radiopharmacy and chemistry
Author(s)
Cusnir R., Leresche M., Pilloud C., Straub M.
ISSN
2365-421X (Electronic)
ISSN-L
2365-421X
Publication state
Published
Issued date
11/10/2021
Peer-reviewed
Oui
Volume
6
Number
1
Pages
35
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
Nanocolloidal human serum albumin radiolabelled with <sup>99m</sup> Tc provides a diagnostic radiopharmaceutical for sentinel node lymphoscintigraphy. NanoHSA (Nanotop), a commercially available kit, enables the simple preparation of this radiopharmaceutical via reconstitution with pertechnetate eluted from a generator. Thin-layer chromatography is widely used for determining radiochemical purity in clinical nuclear medicine. Quality control methods recommended by the manufacturer were sometimes reported to yield variable results. Therefore, we proposed and evaluated three alternative thin-layer chromatography methods for the quality control of [ <sup>99m</sup> Tc]Tc-NanoHSA from a commercially available kit.
The radiochemical purity of [ <sup>99m</sup> Tc]Tc-NanoHSA determined with all methods was reproducible and met the requirements of the SPC and the European Pharmacopoeia (≥ 95%). Our quality control using iTLC-SG chromatographic paper in methyl ethyl ketone mobile phase identified only free pertechnetate as impurity, resulting in > 99% RCP. The quality control using iTLC-SG in 85% methanol or iTLC-SA in 0.9% NaCl identified an additional small fraction of a hydrophilic impurity, resulting in 95-97% RCP. Glucose was identified as a potential <sup>99m</sup> Tc-carrying hydrophilic species contributing to hydrophilic impurities.
Our quality control of [ <sup>99m</sup> Tc]Tc-NanoHSA with non-polar mobile phase tended to underestimate the amount of hydrophilic impurities, although without compromising the final quality of the radiopharmaceutical. Alternative TLC methods using aqueous mobile phases enabled a more accurate determination of hydrophilic impurities.
Keywords
99mTc, Glucose, Lymphoscintigraphy, NanoHSA, Nanocolloidal albumin, Nanotop, Radiochemical purity, Sep-Pak®, Thin-layer chromatography
Pubmed
Web of science
Open Access
Yes
Create date
19/10/2021 12:31
Last modification date
09/03/2022 7:34
Usage data